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Behavioral Intervention

Wait-listed for Human Immunodeficiency Virus Infection (IA Trial)

Q: Does my profile qualify me to join this clinical study?

<p>This <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-focused clinical trial has an age threshold of 18 to 44 years and is recruiting around 66 volunteers.</p>

N/A

Waitlist Available

Led By Natalia Villegas Rodriguez, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 months

Awards & highlights

IA Trial Summary

This trial tests a telenovela intervention to increase condom use, HIV testing, PrEP awareness and use, and decrease substance abuse, intimate partner violence, and depression among Latinas.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection

IA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Condom Use from Baseline to Month 1

Change in Condom Use from Baseline to Month 4

Change in HIV Test Perception from Baseline to Month 1

+9 more

Secondary outcome measures

Change in Depression

Change in Intimate Partner Violence (IPV)

Change in Substance Abuse from Baseline to Month 4

+2 more

Other outcome measures

Change in Emotional Response

Change in Narrative Engagement

Change in Self-Efficacy for Condom Use from Baseline to Month 1

+6 more

IA Trial Design

2Treatment groups

Experimental Treatment

Group I: Wait-listedExperimental Treatment1 Intervention

A wait-listed control group of 33 Latinas will receive IA in the same manner as the intervention group. Latinas will start watching the telenovela episodes 4 months after their baseline survey (after T3 survey). Latinas will be informed at recruitment of this group condition and the study randomization. During the waiting time, participants will be called on a monthly basis to encourage participation and refer to services if needed.

Group II: Infeccion de Amor (Love Infection)Experimental Treatment1 Intervention

33 Latinas will view four IA intervention episodes, one per week immediately after the baseline survey and orientation. Participants will receive an email to their preferred email address with a password to access to the episode on the IA's website: https://www.infecciondeamor.com. Each 10-minute episode can be watched more than once during the week and presents a situation with notable HIV risk and ways the characters avoided risk (e.g., condom use) or confronted consequences of poor practices (e.g., HIV infection). The one-week time frame for each episode is needed to provide time to review and reflect about IA's content and modify HIV prevention behaviors. It will also allow Latinas to obtain information and support from the team and referral if needed. This time frame was effective to improve behaviors in previous studies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Infeccion de Amor (Love Infection)

2022

N/A

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

North Carolina Translational and Clinical Sciences InstituteOTHER

56 Previous Clinical Trials

4,245 Total Patients Enrolled

University of North Carolina, Chapel HillLead Sponsor

1,510 Previous Clinical Trials

4,193,035 Total Patients Enrolled

Natalia Villegas Rodriguez, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers being accepted for this trial currently?

"Clinicaltrials.gov confirms this trial is in progress, having been first published on May 10th 2022 and most recently updated on July 11th 2022."

Answered by AI

Does the research endeavor enlist individuals who are 55 years and above?

"This research requires participants that are between 18 and 44 years of age."

Answered by AI

Does my profile qualify me to join this clinical study?

"This HIV-focused clinical trial has an age threshold of 18 to 44 years and is recruiting around 66 volunteers."

Answered by AI

How many participants are being recruited for this trial?

"Affirmative. The clinical trial details hosted on clinicaltrials.gov demonstrate that the study, which was initiated on May 10th 2022, is actively recruiting participants. 66 subjects are needed across one medical site for this research endeavour."

Answered by AI

What is the desired outcome of this experiment?

"The primary metric analysed in this trial to determine success is the Change in Condom Use from Baseline to Month 4. Meanwhile, secondary outcomes involve changes in Depression (assessed with a PHQ-9 scale ranging 5-27), Substance Abuse (with a 6-36 point range) and Intimate Partner Violence (a 24-72 point revised Conflict Tactics Scale)."

Answered by AI

Recent research and studies

American Journal of Public HealthJournal

The Effects of HIV/AIDS Intervention Groups for High-risk Women in Urban Clinics.

Kelly, J A, D A Murphy, C D Washington, T S Wilson, J J Koob, D R Davis, G Ledezma, and B Davantes. 1994. “The Effects of HIV/AIDS Intervention Groups for High-risk Women in Urban Clinics.”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.84.12.1918.

World Medical & Health PolicyJournal

Evaluating a Culturally Tailored HIV Risk Reduction Intervention Among Latina Immigrants in the Farmworker Community

Sanchez, Mariana, Patria Rojas, Tan Li, Gira Ravelo, Elena Cyrus, Weize Wang, Mariano Kanamori, Nilda P. Peragallo, and Mario R. De La Rosa. 2016. “Evaluating a Culturally Tailored HIV Risk Reduction Intervention Among Latina Immigrants in the Farmworker Community”. World Medical & Health Policy. Wiley. doi:10.1002/wmh3.193.

International Nursing ReviewJournal

The Development, Feasibility and Acceptability of an Internet-based STI-HIV Prevention Intervention for Young Chilean Women

Villegas, N., D. Santisteban, R. Cianelli, L. Ferrer, T. Ambrosia, N. Peragallo, and L. Lara. 2014. “The Development, Feasibility and Acceptability of an Internet-based STI-HIV Prevention Intervention for Young Chilean Women”. International Nursing Review. Wiley. doi:10.1111/inr.12080.

Violence and VictimsJournal